Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— AGRA  

Official title:

Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667758
• Other study ID #: R1/05
• Secondary ID: 2007/2/0174
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2008
• Last updated: August 3, 2012
• Start date: May 2008
• Est. completion date: October 2011

Study information

• Verified date: August 2012
• Source: Betanien Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Directorate of HealthNorway: Data Protection AuthorityNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult between 18 years and above

• Moderate to severe disease activity

• Negative pregnancy test for women of childbearing potential

• Use of reliable method of contraception (non-hormonal) by sexually active female patients

Exclusion Criteria:

• Patients who are pregnant or breastfeeding

• Patients taking biologic therapy or prednisolone >7.5mg

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Cetrorelix
3-5 mg s.c. on days 1-5
• Placebo
3-5 ml NaCl s.c. on days 1-5

Locations

Country	Name	City	State
Norway	Deaprtment of Rheumatology, Betanien Hospital	Skien

Sponsors (3)

Lead Sponsor	Collaborator
Betanien Hospital	Norwegian Foundation for Health and Rehabilitation, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group		From baseline to day 5	No
Secondary	Change in DAS28 (CRP/ESR)		From baseline to day 2/5 /10/15	No
Secondary	Change in anti-CCP level		From baseline to day 2/5/10/15	No
Secondary	Change in cytokine level		From baseline to day 2/5/10/15	No
Secondary	Change in ACR core set measures		From baseline to day 2/5/10/15	No
Secondary	Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders		Baseilne to day 2/5/10/15	No
Secondary	Adverse events	Number of patients with adverse events (and serious adverse events) up to day 15 in each group	Baseline up to day 15	Yes
Secondary	Proportion of patients with DAS28low disease activity/remission		Baseline to day 2/5/10/15	No
Secondary	Change in HAQ scores		From baseline to day 5/10/15	No
Secondary	Correlation between percent changes in hormones, disease activity and biomarkers	This endpoint is not directly related to clinical efficacy. Hormones include LH, FSH, oestradiol, testosterone,and cortisol. Biomarkers include immunologic markers, bone markers and cardiovascular markers. This secondary endpoint was sent to authorities during the study before unblinding.	By day 2, 5, 10 and 15	No